Detection of PCOS by Sensors Array

February 12, 2017 updated by: Meir Medical Center

Detection of PCOS and Ovulation Timing by NA-Nose

Detection of metabolic state of women with polycystic ovary using NA-Nose.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Breath of women undergoing fertility treatment including PCOS and ovulatory women will be collected and transferred for our labs for further analysis in define the metabolic state. The detection will be made using sensors arrays and GCMS.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:women undergoing follow up for ovulation detection. -

Exclusion Criteria:Pregnancy

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ovulatory
Comparison in metabolic state between ovulatory and PCOS women by collecting breath test from participant.
Diagnostic test: Breath test
Collecting breath test from participants
Active Comparator: PCOS
Comparison in metabolic state between ovulatory and PCOS women by collecting breath test from participant
Diagnostic test: Breath test
Collecting breath test from participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of different metabolic state between groups.
Time Frame: two years
Finding that there special markers in the breath test that indicate a different metabolic state in PCOS.
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2017

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

February 6, 2017

First Submitted That Met QC Criteria

February 6, 2017

First Posted (Estimate)

February 8, 2017

Study Record Updates

Last Update Posted (Actual)

February 14, 2017

Last Update Submitted That Met QC Criteria

February 12, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 020916COM1k

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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